Acupuncture vs Sham Acupuncture or Waitlist Control for Patients With Chronic Planter Fasciitis

NCT04185259 | Unknown DMC

• 1 other identifier: ZZ13-YQ-019
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Plantar fasciitis (PF) predominantly affects elderly and middle-aged individuals and is more frequent in runners or those whose employment requires standing. The available treatment options of PF mainly included non-operative treatments (e.g., plantar fascia and gastrocnemiussoleus muscle stretching, heel cups, arch supports, night splints, nonsteroidal antiinflammatory drugs (NSAIDs), local corticosteroid injections) and operative management. However, no consensus has been reached regarding the most beneficial treatment method for PF. Acupuncture has been used in the management of PF and the other musculoskeletal pain-related conditions for thousands of years. Recent two systematic reviews have found that acupuncture may reduce pain intensity and improve plantar function for patients with PF. However, there are methodological problems with small sample size, or not controlled with a placebo/waitlist group, or not account for the confounding effects of patients who experienced combination treatments in the design of the included acupuncture literature. Therefore, the placebo effect of acupuncture and a possible spontaneous remission for PF cannot be excluded and the beneficial effects of acupuncture for PF remained need to more assessment. The investigators designed a randomized controlled trial to evaluate the efficacy of Traditional Chinese acupuncture (TCA), compared with sham acupuncture (SA) or being on a waitlist control group (no acupuncture treatment), for patients with chronic PF for ≥ 6 months. The hypothesis was that combined acupuncture and sham acupuncture will result in larger improvements in heel pain more than no acupuncture treatment in patients with chronic PF. Secondary hypotheses examined whether acupuncture reduce heel pain intensity more effectively than sham acupuncture or no acupuncture.

Conditions

Plantar Fasciitis

Outcome Measures

Primary Outcomes (1)

• The proportion of participants with treatment response 4 weeks after randomization

  A treatment responder is defined as a participant having a minimum of 50% improvement in the worst pain intensity during the first steps in the morning compared with baseline.

  at week 4

Secondary Outcomes (8)

• Changes in VAS score for worst pain intensity during the first steps in the morning from baseline to 4 weeks, 8 weeks and 16 weeks after randomization

  at week 4, week 8 and week 16

• Changes in VAS score for mean pain intensity during the day from baseline to 4 weeks, 8 weeks and 16 weeks after randomization

  at week 4, week 8 and week 16

• Changes in the pressure pain threshold (PPT) at the most painful area from baseline to 4 weeks, 8 weeks and 16 weeks after randomization

  at week 4, week 8 and week 16

• Changes in ankle range of motion (AROM) from baseline to 4 weeks, 8 weeks and 16 weeks after randomization

  at week 4, week 8 and week 16

• Changes in Foot and Ankle Ability Measure (FAAM) total score and subscale scores from baseline to 4 weeks, 8 weeks and 16 weeks after randomization

  at week 4, week 8 and week 16

Other Outcomes (3)

• Participants'expectation towards acupuncture

  at baseline

• The proportion of participants who have maintained blinding during treatment in acupuncture and SA groups

  at week 4

• Incidence of adverse events

  weeks 1-16

Study Arms (3)

Acupuncture group

EXPERIMENTAL

Other: Acupuncture

Sham acupuncture

SHAM COMPARATOR

Other: Sham acupuncture

Waitlist control group

NO INTERVENTION

Participants will receive no treatment for their heel pain for a period of 16 weeks after randomization, and subsequently have the option of 4 weeks (12 sessions) of acupuncture with free of charge at the end of follow-up.

Interventions

Acupuncture OTHER

The investigators will apply two Ashi points (the two most severe tender points in the most sensitive area over the anteromedial aspect of the heels), Chengshan (BL57), Taixi (KI3) and Kunlun (BL60) in this trial. With the patient in a prone position, the local skin will be routinely sterilized followed by a 10mm diameter and 5mm thick sterile adhesive pad pasting onto each selected acupoint. Ashi points will be perpendicularly inserted through the pad to the plantar fascia layer with a depth of approximately 15-20mm depending on the location. BL57, KI3 and BL60 will be punched perpendicularly 10-15mm deep into the skin through the pad. All needles except Ashi points will be manually stimulated by small, equal manipulations of lifting, thrusting, twirling and rotating to achieve De qi. Needles will be retained for 30 minutes per treatment. During each treatment, every needle will be manipulated three times every 10 minutes.

Acupuncture group

Sham acupuncture OTHER

Sham Ashi (0.5 cun away from Ashi, one 'cun' is equivalent to the greatest width of the individual patients' thumb, \~1.5 cm), sham BL57 (0.5 cun lateral to true BL57 horizontally), sham KI3 (midway between true KI3 and heel tendon) and sham BL60 (midway between true BL60 and heel tendon) will be used. Treatment protocol will be similar to that of the acupuncture group. The Hwato-brand disposable blunt-tipped needles (size 0.30 × 25 mm) will be inserted at sham points through adhesive pads to the skin without skin penetration. The needles will then be lifted, thrusted, twirled, and rotated evenly three times every ten minutes. No specific de qi response will be elicited.

Sham acupuncture

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years and ≤75 years;
• History of planter medial heel pain for at least 6 months before enrolment;
• Reported an average worst pain intensity at first steps in the morning over the last 7 days of at least 50mm on a 100-mm visual analog scale (VAS) before enrolment;
• Failure to respond to conservative treatment for ≥ 1 months, including any of the following modalities: stretching exercises, nonsteroidal anti-inflammatory drugs, orthotics;
• Ability to comply with the study protocol, understand the medical information forms as well as having signed informed consent.

You may not qualify if:

• History of calcaneus fracture, calcaneal bone tumor or cyst, plantar fascia rupture， or have a significant foot deformity(clubfoot, pes cavus, or pes calcaneovalgus);
• Previous injection (corticosteroid, platelet-rich plasma, lidocaine needling), or radiation, or surgery to plantar fascia within 6 months preceding enrollment;
• Radiculopathy or peripheral neuropathy around the ankle joint such as nerve entrapment tarsal tunnel syndrome or Achilles tendinopathy;
• Systemic disorders like rheumatoid arthritis, gout, Reiter syndrome, type 1 or 2 diabetes mellitus, osteoporosis, spondyloarthritis, or osteomyelitis;
• Joint, bone, or skin infection in the affected foot;
• Clinically significant cardiovascular disorder, severe hepatic/renal insufficiency or coagulation disorder at baseline as determined by the investigator;
• Known phobic to acupuncture or received acupuncture treatment within 4 weeks prior to enrollment.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital

Beijing, China

RECRUITING

Related Publications (1)

• Wang W, Liu S, Liu Y, Zang Z, Zhang W, Li L, Liu Z. Efficacy of acupuncture versus sham acupuncture or waitlist control for patients with chronic plantar fasciitis: study protocol for a two-centre randomised controlled trial. BMJ Open. 2020 Sep 25;10(9):e036773. doi: 10.1136/bmjopen-2020-036773.

  PMID: 32978188 DERIVED

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Zhishun Liu, MD, PhD

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiming Wang, MD, PhD

CONTACT

010-88001241; wangweiming1a1@163.com

Zhishun Liu, MD, PhD

CONTACT

010-88002331; zhishunjournal@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants in acupuncture group and sham acupuncture group, together with efficacy evaluators and data analysts will be blinded to the group assignments. Participants in the waitlist control group and acupuncturists will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized to acupuncture group, sham acupuncture group, or waitlist (no acupuncture) group at a ratio of 2:1:1 using simple randomization.

Study Record Dates

• First Submitted: November 30, 2019
• First Posted: December 4, 2019
• Study Start: December 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: August 1, 2022
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)